Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version.
Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version.
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DOI：
10.1186/s12910-021-00699-z
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发表时间：
2021-09-28
影响因子：
2.7
通讯作者：
Wang X
中科院分区：
文献类型：
--
作者：
Liu X;Wu Y;Yang M;Li Y;Hahne J;Khoshnood K;Coleman L;Wang X
使用有效的方法来评估机构审查委员会（IRB）的绩效对于确保IRB的有效性、效率以及遵守适用的人类研究标准和组织政策至关重要。目前，国内还没有一项实证研究通过使用标准化的工具来评估内部评级法的绩效。因此，本研究开发了IRB研究人员评估工具（IRB-RAT）的中文版，评估了中文版（IRB-RAT-CV）的心理测量学特性，并验证了该工具在中国的使用。在这项文化适应、横断面验证研究中，IRB-RAT-CV通过回译过程开发，然后分发给湖南省医疗机构和学校的587名IRB工作人员和研究人员，审查生物医学和社会行为研究。从参与者中收集的470份有效问卷的数据被用来评估IRB-RAT-CV的信度，内容效度和结构效度。通过IRB-RAT-CV测量，参与者对理想和实际IRB的评分分别达到Cronbach α 0.989和0.992，Spearman-Brown系数0.964和0.968，项目-总相关值范围分别为0.631至0.886和0.743至0.910。IRB-RAT-CV是一种在语言和文化上适用的工具，用于评估中国IRB的质量。
Using an effective method for evaluating Institutional Review Board (IRB) performance is essential for ensuring an IRB’s effectiveness, efficiency, and compliance with applicable human research standards and organizational policies. Currently, no empirical research has yet been published in China evaluating IRB performance measures by the use of a standardized tool. This study was therefore conducted to develop a Chinese version of the IRB Researcher Assessment Tool (IRB-RAT), assess the psychometric properties of the Chinese version (IRB-RAT-CV), and validate the tool for use in China. In this cultural adaptation, cross-sectional validation study, the IRB-RAT-CV was developed through a back-translation process and then distributed to 587 IRB staff members and researchers in medical institutions and schools in Hunan Province that review biomedical and social-behavioral research. Data from the 470 valid questionnaires collected from participants was used to evaluate the reliability, content validity, and construct validity of the IRB-RAT-CV. Participants’ ratings of their ideal and actual IRB as measured by the IRB-RAT-CV achieved Cronbach's alpha 0.989 and 0.992, Spearman-Brown coefficient 0.964 and 0.968, and item-total correlation values ranging from 0.631 to 0.886 and 0.743 to 0.910, respectively. The IRB-RAT-CV is a linguistically and culturally applicable tool for assessing the quality of IRBs in China.
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影响因子：
2.7
作者：
Sleem H;El-Kamary SS;Silverman HJ
通讯作者：
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影响因子：
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作者：
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通讯作者：
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DOI：
10.1177/1556264615612195
发表时间：
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